Abdominal Surgery Clinical Trial
Official title:
Impact of Nociceptive-Level (NOL) Intraoperative Guided Remifentanil Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery
The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP). The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients. The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.
The PMD-200 continuous pain monitor is intended to be used for assessing changes in pain levels. The system monitors the physiological responses to pain using a relative pain index from 0-100, called the Nociception Level (NOL®) index. In the NOL index, 0 represents no nociception or pain and 100 represents high nociception or pain level. The PMD-200 system consists of a monitor and a specific finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP). The PMD-200™ is intended to be used for assessing the nociception level in anesthetized patients. The device is European Conformity (CE) marked and commercially available. Meier et al. recently published a randomized trial involving 80 patients for major abdominal surgery, one group receiving routine care and the other NOL-guided analgesia. In the latter group, the remifentanil concentration was reduced when NOL values were below 10 or increased when NOL values were above 25 for at least 1 minute. In both groups, propofol was titrated to have bispectral index values between 45 and 55. Remifentanil administration was reduced in the NOL-guided group: 0.119 ± 0.033 vs 0.086 ± 0.032 μg.kg.min (p < 0.001). In the NOL- guided group, 2 out of 40 (5%) patients had hypotension (mean blood pressure less than 55 mm Hg) compared to 11 out of 40 (28%) in the control group (p = 0.006) and 16 out of 40 (40%) patients received vasoactive drugs vs 25 out of 40 (63%) (p = 0.044). Previous results cover a small number of patients treated in a single center. The purpose of this study is to confirm this result within a multicenter study involving a larger group of patients. Confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL will open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01611376 -
Impedance Cardiography During Major Abdominal Surgery
|
Phase 4 | |
| Recruiting |
NCT05556174 -
Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers
|
N/A | |
| Completed |
NCT03633123 -
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
|
Phase 2 | |
| Terminated |
NCT03684304 -
The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery
|
N/A | |
| Active, not recruiting |
NCT02817893 -
Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
|
N/A | |
| Completed |
NCT04120740 -
Validation of Two Acitivity Monitors in Three Inpatient Populations.
|
||
| Recruiting |
NCT03700749 -
FALCON Trial Testing Measures to Reduce Surgical Site Infection
|
Phase 3 | |
| Completed |
NCT01389648 -
Pre-operative Physiotherapy to Prevent Post-operative Complications
|
N/A | |
| Withdrawn |
NCT00557843 -
Continuous Bupivacaine Infusion Following Colonic Surgery
|
N/A | |
| Active, not recruiting |
NCT01839617 -
Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery
|
N/A | |
| Terminated |
NCT04887922 -
Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
|
N/A | |
| Completed |
NCT04730141 -
Effect of Mobilization Protocol on Mobilization
|
N/A | |
| Completed |
NCT00683150 -
Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring
|
N/A | |
| Active, not recruiting |
NCT03933306 -
Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes
|
Phase 4 | |
| Recruiting |
NCT05268432 -
Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
|
||
| Not yet recruiting |
NCT04747535 -
Continuous Positive Airway Pressure After Abdominal Surgery
|
N/A | |
| Not yet recruiting |
NCT05253586 -
Versius Or Laparoscopic Abdominal Hernia REpair
|
||
| Recruiting |
NCT06374849 -
Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery
|
Phase 4 | |
| Recruiting |
NCT05246605 -
Postoperative Hypoxia and Body Position
|
N/A | |
| Recruiting |
NCT04685876 -
Comparing TAP Blocks Bupivacaine, and Placebo for Plane
|
Phase 3 |